Systems and methods for bone fixation

ABSTRACT

Systems and methods for bone fixation are disclosed. A fixation system can have a planar fixation device and a laterally-fixed fixation apparatus. The planar fixation device can have a planar surface and at least one opening having side walls defining an at least generally cylindrical shape. The laterally-fixed fixation apparatus can have an at least generally cylindrical shaped head portion having outer wall sections at least partially surrounding a central hollow area. The head portion can have an inner bottom surface. An expander hub is provided in the fixation apparatus for positioning at least partially within the central hollow area of the head portion and can be seated at least partially on the inner bottom surface of the head portion. The expander hub is rotatable to force the outer wall sections of the head portion outwardly for engaging and locking the fixation apparatus in place in the opening. The fixation apparatus is further adapted for rotation about a longitudinal axis of the fixation apparatus without lateral toggle movement relative to the planar surface of the planar fixation device. In other aspects, systems for fixating an orthopedic guide and systems and methods for compressing bone portions are also provided.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 60/631,951, filed Nov. 30, 2004 and U.S. patentapplication Ser. No. 11/010,825, filed Dec. 13, 2004, the disclosures ofwhich are incorporated herein by reference.

TECHNICAL FIELD

The present subject matter relates generally to bone fixation and, moreparticularly to systems for bone fixation utilizing a plate and fixationapparatus system to lock in variable or fixed locked positions in orderto fixate bone; systems for fixating an orthopedic guide; and systemsand methods for compressing bone portions.

BACKGROUND ART

A variety of apparatuses and methods are known in the field oforthopedics for reducing, fixing and generally assisting the healing offractured bones. In some cases, these apparatuses and methods requiresurgical intervention. Open reduction internal fixation (ORIF) is adeveloped art with respect to some portions of the body; however, manycomplications can exist which can prevent successful or optimal outcomesin all cases utilizing ORIF. Treatment methods can also significantlyimpact healing time, pain and functional outcomes. Moreover, thenecessity of reducing operative time is driven both by patient risk ofinfection, and aesthetic complications, and health care costs. Thus,efforts continue to be made to improve fixation devices and surgicaltechniques in an attempt to improve surgical outcomes, costs andoperative times.

Several factors are considered to be well known which can havesignificant impact in predicting outcomes of ORIF. These factorsinclude:

1. Prominence of hardware, leading to soft tissue abrasion and generalinflammation.

2. Accurate reduction of fracture site providing proper alignment in alldegrees of freedom.

3. Reliable fixation that rigidly approximates bone segments duringhealing.

4. Production of adequate and predictable compression across fracturesites which provides impetus for improved healing.

5. Minimization of skin incision and exposure to patient.

6. Reduced operative times.

Thus, it is desirable to utilize a fracture fixation apparatus andmethod which provides for low-profile hardware, or hardware countersunkinto bone, which reduces or eliminates soft tissue abrasions andinflammation. Additionally, it is desirable to utilize an apparatus andmethod that provides for reproducible reduction, fixation, and alsoaccurate bone compression to optimize the healing process. Such anapparatus and method must also minimize skin incision and provide amethod that is simple and timely in terms of operating room resourcesand patient risk. Since fractures can occur in all bones of the body,both large and small, it is further desirable to utilize a consistentapparatus and method that can be used and scaled to fit all sizeapplications regardless of the size of a bone fracture.

Fixation plates are common apparatuses used in orthopedic surgery forfixing two or more bone fragments together. Commonly, a plate withseveral holes defined in the plate is placed adjacent to bone fragments,and screws are driven through the plate holes and into the bonefragments. This method can often provide a satisfactory reduction andfixation where sufficient bony material is available for firmly graspingand orienting a screw/plate construct. More specifically, when afixation apparatus is able to penetrate and engage two bone cortices,the fixation apparatus is firmly supported in two locations and willthus be rotationally aligned with the plate. If the fixation apparatusis, however, only able to grasp one cortice, and in a normal case, theproximal cortice, rotational alignment is not firmly engaged between thefixation apparatus and the plate and accurate reduction of the fixationsite may not be maintained. This problem is also common in the areas ofthe body not involving particularly long bones, such as the hand, footand spine. This problem also commonly exists in unhealthy (rheumatoid orosteoporotic) bone that simply cannot purchase bone as firmly as healthybone.

A variety of apparatuses and methods have existed and exist in the priorart relating to bone fracture repair. The first generation of designsfor screw/plate hardware used in fracture repair consisted of simplydesigned mechanisms using conventional hardware and materials compatiblewith the application. There was little effort to reduce the profile toprotect soft tissue or control the position. The second generation addedto the technology of the first generation by simply making allowance forthe screw to sit into the profile of the plate (countersunk) so thatsoft tissue abrasion was minimized.

The third generation utilized a spherical countersunk screw in platedesign as it became evident as plates were used more widely through thebody that it was desirable to allow the screw to be positioned in manyor a range or angles relative to the plate. By creating a sphere andglobular socket mechanism, a solid construct could be obtained with thescrew at any angle to the plate. The fact that the screw can engage twocortices allowed the angle to be fixed. The fourth generation utilized afixed angle countersunk screw in plate design as screw and platemechanisms were continually used in smaller and more complex regions ofthe body. There was a need to be able to hold bony structures rigidly insituations where little inherent support was available. A fixed anglebetween the screw and plate was created by threading the head of thescrew into the plate. The angle of the screw relative to the plate wasdetermined at manufacture of the hardware. This technology isrepresented at least in part by U.S. Pat. No. 6,440,135 to Orbay et al.

One invention currently sold under the mark PEAK by DePuy Acromed(Raynham, Mass.) is disclosed in U.S. Pat. No. 5,954,722 to Bono. Theapparatus described in this patent utilizes a plate with holes whichhave spherical diameter bores into which fit spherical outer diameterbushings. The bushings have a tapered, threaded inner diameter, and aspecially designed screw is available that has a tapered head matchingthat of the bushing. As the screw is driven through the bushing, thethreads engage and produce a radial force in the bushing, pushingagainst the inner wall of the plate. The alignment of the screw to theplate is held with a moment corresponding to the amount of frictionbetween the bushing and the plate. Primary shortcomings of thisapparatus include:

1. The angle of the screw must be determined prior to insertion of thescrew.

2. The screw cannot optionally be allowed to remain unlocked as alocking construct must be used.

3. The locking mechanism requires careful planning upon insertion aslong as there is propensity for “cross-threading” the construct due toits fine thread and long length.

4. Compression of bone with the screw independent of locking the screwin place is either not possible or is limited.

SUMMARY

As disclosed herein, novel systems and methods for bone fixation areprovided in accordance with the present subject matter.

An object of the present disclosure is to provide novel and improvedsystems and methods for bone fixation. An object having been stated, andwhich is achieved in whole or in part by the present subject matter,other objects will become evident as the description proceeds when takenin connection with the accompanying drawings as best describedhereinbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 of the drawings is a perspective view of an embodiment of afixation apparatus with an expander hub shown detached;

FIG. 2 of the drawings is a side view of the fixation apparatus shown inFIG. 1 without the expander hub;

FIG. 3 of the drawings is a sectional view of an end portion of thefixation apparatus shown in FIG. 2;

FIG. 4 of the drawings is an end view of the fixation apparatus shown inFIG. 2;

FIG. 5A of the drawings is a perspective view of the expander hub shownin FIG. 1;

FIG. 5B of the drawings is a top plan view of the expander hub shown inFIG. 1;

FIG. 5C of the drawings is a side elevation view of the expander hubshown in FIG. 1;

FIG. 5D of the drawings is a sectional view of the expander hub shown inFIG. 5C;

FIG. 6 of the drawings is a sectional view of an end portion of thefixation apparatus of Figure shown in FIG. 2 with the expander hub inplace;

FIG. 7A-7C of the drawings are end views of the head portion of thefixation apparatus shown in FIG. 6 illustrating various positions of theexpander hub;

FIG. 8 of the drawings is a sectional view of and end portion of thefixation apparatus of FIG. 6 illustrating the expander hub in a lockedposition;

FIG. 9A of the drawings is a sectional view illustrating a portion ofthe fixation apparatus with the expander hub in an unlocked position;

FIG. 9B of the drawings is a sectional view illustrating a portion ofthe fixation apparatus with the expander hub in a locked position;

FIG. 10 of the drawings is a sectional view illustrating two fixationapparatuses locked in place against a plate to fixate a fracture;

FIGS. 11A-11C of the drawings are perspective views of drivers that canbe used in association with the fixation apparatus shown in the previousfigures;

FIG. 12A-12C of the drawings are perspective views of the head portionsof the drivers of FIGS. 11A, 11B and 11C, respectively;

FIG. 13 of the drawings is a perspective view of the drivers of FIGS.11A-11C and 12A-12C assembled together for use;

FIG. 14 of the drawings is a sectional view of the assembly of driversof FIG. 13 positioned against the fixation apparatus for use;

FIG. 15 of the drawings is a sectional view illustrating a fixationsystem including a laterally-fixed fixation apparatus and alaterally-variable fixation apparatus locked in place against a plate;

FIG. 16 of the drawings is a side view of the laterally-fixed fixationapparatus shown in FIG. 15;

FIGS. 17A and 17B of the drawings are perspective views of an embodimentof a guide fixation apparatus with an expander hub shown detached;

FIG. 18 of the drawings is a side view of the guide fixation apparatusshown in FIGS. 17A and 17B with the expander hub attached and engagedwith a plate; and

FIG. 19 of the drawings is a sectional view illustrating two guidefixation apparatuses and a guide locked in place against two plates tofixate a fractured bone.

DETAILED DESCRIPTION

In accordance with the subject matter disclosed herein, and withreference to the various figures of drawings, apparatuses, systems andmethods are provided for fixating a fractured bone with the ability toestablish and maintain accurate alignment and reduction of bonefragments as well as to maintain such reduction through the healingprocess. As described in detail hereinbelow, a fixation apparatus inaccordance with the present disclosure can be utilized in associationwith a plate in order to achieve and maintain desired alignment,independent of the level of fixation, in order to facilitate healing ofa bone fracture.

Referring now to FIGS. 1 and 2 of the drawings, fixation apparatusgenerally designated FA is illustrated and comprises a head portiongenerally designated H which can have a shank portion generallydesignated SP extending therefrom. An expander hub generally designatedEH is shown in FIG. 1 adapted for fitting into head portion H asdescribed later in greater detail and as shown forth for illustrationpurposes in FIG. 1 detached from head portion H. As can be appreciatedby those of skill in the art, shank portion SP can be formed as anintegral part of and extension from head portion H or can separate andindependent from head portion H.

Shank portion SP can be any suitable shank portion, threaded orunthreaded, and is illustrated in the drawings in one suitable,non-limiting configuration. As shown in FIGS. 1 and 2, a threaded shankportion SP of fixation apparatus FA can include any suitable type ofthread, such as threads 100, along at least a portion of the length ofshank portion SP and can also include a tip 110 which can beself-tapping, for facilitating screwing or otherwise placing fixationapparatus FA into bone. As can be appreciated by those of skill in theart, shank portion SP of fixation apparatus FA can be cannulated ifdesired and define an axial opening along the middle of shank portion SPShank portion SP can be self-drilling and can be constructed of anysuitable material known to those of skill in the art, such as, forexample, titanium.

Head portion H of fixation apparatus FA can be integral with or separatefrom and attached to an end of shank portion SP opposite from the end ofshank portion SP which includes tip 110. Head portion H can be of anysuitable shape in accordance with the functionality described in thepresent disclosure and can be constructed of any suitable material knownto those of skill in the art, such as, for example, titanium. One ormore slots, such as slots 200 can be defined through portions of thewall of head portion H thereby creating wall sections 210 which areseparated by slots 200 as illustrated, but that all extend from a baseportion 220 of head portion H with base portion 220 being the part ofhead portion H closest to shank portion SP.

Expander hub EH of fixation apparatus FA can be of any suitable shape orconfiguration for functionality in accordance with the presentdisclosure as will be appreciated by those of skill in the art. Asillustrated, expander hub EH is at least generally cylindrical in shapewith a reverse, tapered outer diameter and an inclined, lower surface asdescribed in greater detail hereinbelow. Expander hub EH can have aplurality of annular recesses and is adapted for fitting into a recessedportion of head portion H of fixation apparatus FA where it can bepositioned in a disengaged or unlocked position wherein wall sections210 of head portion H are not forced outwardly, and an engaged or lockedposition wherein wall sections 210 of head portion H are forcedoutwardly sufficient to lock fixation apparatus FA in a predeterminedposition as described further hereinbelow. As with the previousstructures, expander hub EH can be constructed of any suitable materialknown to those of skill in the art, such as, for example, titanium.

As shown in FIGS. 1 and 2 (and FIG. 10 described below) of the drawings,head portion H can advantageously comprise a groove G that can bedefined in the lower portion of head portion H and allows head portion Hto be self-counterboring into bone. Screw heads with additionalfeatures, such as locking, can often be thicker than desired such thatbone has to be countersunk to allow the screw head to sit in a thinnerplate. This countersinking requires an additional step, therefore makingthe self-counterboring feature of head portion H quite advantageous.

Referring now to FIG. 3 of the drawings, a cross-sectional view of headportion. H and shank portion SP of fixation apparatus FA is illustrated.Expander hub EH is not present in FIG. 3. Shank portion SP can be of anysuitable design with outer threads 100 adapted for screwing into bone.Head portion HP, however, advantageously comprises slot 200, wallsections 210 and base portion 220 as illustrated in FIG. 3 wherein baseportion 220 includes a recess designated 230. Recess 230 is perhaps bestillustrated in FIGS. 3 and 4 of the drawings and can be of any suitableshape or configuration adapted for receiving a driver in order torotatably drive head portion H and shank portion SP when present andwhen desired such as when shank portion SP is threaded for screwingshank portion SP into bone. As shown in FIG. 4, recess 230 of baseportion 220 defines a hexagonal configuration adapted to receive asuitably shaped driver with a matching hexagonal end for being matinglyreceived into recess 230 for rotatably driving head portion H and shankportion SP.

Still referring to FIGS. 3 and 4 primarily, recess 230 of base portion220 is advantageously defined in an upper surface 240 of base portion220 of head portion H. Upper surface 240 is preferably slightly inclinedfrom one side of head portion H to the other as illustrated in FIG. 3 tofacilitate the locking feature of expander hub EH (shown in FIG. 1) whenpositioned in head portion H as described further hereinbelow. Thehollow or recessed portion of head portion H at least partiallysurrounded by wall sections 210 can be of a larger diameter at thebottom thereof (at upper surface 240 of base portion 220) than at thetop end 250 of head portion H. To achieve this feature, the innerportions or sides 260 of wall sections 210 facing the interior of headportion H can have a reverse taper and extend gradually further inwardlythe further they extend from upper surface 240 of base portion 220.Slots 200 of head portion H as illustrated in FIG. 3 can be defined fromtop end 250 of head portion H to base portion 220 and extend along aline that is at least generally parallel to a longitudinal, central axisof shank portion SP. Groove G (shown in FIGS. 1 and 2) can be defined inthe lower portion of head portion H below slots 200 of head portion H inorder for head portion H to be self-counterboring into bone

FIGS. 5A, 5B, 5C and 5D of the drawings illustrate expander hub EH whichis adapted to fit into the recessed portion of head portion H at leastpartially surrounded by wall sections 210 above base portion 220.Expander hub EH can be at least generally cylindrical in shape and havea reverse tapered outer diameter such that the outer diameter ofexpander hub EH is greater at its bottom or lowest surface 300 than theouter diameter of expander hub EH at the opposite uppermost surface 310.Expander hub EH includes an outer wall 320 which can optionally compriseone or more lobes, such as lobes 330, three of which are shown onexpander hub EH in the disclosed embodiments. Lobes 330 can be formed asexpanded bands or portions of outer wall 320 and can be spaced-apartequally on outer wall 320.

When present, lobes 330 can each extend radially past the outer diameterof expander hub EH that is defined by outer wall 320, and lobes 330 canextend from the uppermost surface 310 of expander hub EH to the lowestsurface 300 of expander hub EH. As illustrated in FIGS. 5A-5D, the outerdiameter of expander hub EH at uppermost surface 310 is less than theoutermost diameter of expander hub EH at lowest surface 300. Outer wall320 extends between uppermost surface 310 and lowest surface 300 whereinouter wall 320 can be aligned as illustrated in FIG. 5C at an angle A1of from at least about 2° to 8° from a vertical line designated inphantom as line L1.

As best illustrated in FIGS. 5C and 5D of the drawings, lowest surface300 of expander hub EH can extend along a line that is not parallel withthe line along which uppermost surface 310 extends. Instead, expanderhub EH can include a short side generally designated S1 and a long sidegenerally designated S2 with uppermost surface 310 extendingtherebetween along a line which is at least substantially horizontal butwith lowest surface 300 extending along a line therebetween which can beat an angle A2 of from about at least 6° to 12° from line L2, which isparallel to uppermost surface 310 as illustrated in FIGS. 5C and 5D.

The inner diameter of expander hub EH can be of any suitable shapedesigned for receiving a driver in order to rotate expander hub EH. Asillustrated particularly in FIGS. 5A, 5B and partially in FIG. 5D,expander hub EH includes an inner wall 360 which defines an openingthrough the center of expander hub EH and which can be fixed or moveableinwardly or outwardly. Inner wall 360 forms a shape adapted forreceiving a driver for rotating driving expander hub EH. As shown, innerwall 360 forms a hexagonal recess adapted for receiving a driver with amatching hexagonal driving end for rotating expander hub EH. As can beappreciated by those of skill in the art, any suitable shape can beformed by inner wall 360 in order to suitably rotate expander hub EH. Ascan be appreciated further hereinafter, a driver for fitting into recess230 of base portion 220 of head portion H can be inserted through themiddle of expander hub EH in order to rotate head portion H into shankportion SP as can be appreciated by those of skill in the art. Tofacilitate such a feature, recess 230 of head portion H can be smallerin diametrical size as compared with the central opening defined byinner wall 360 of expander hub EH.

FIG. 6 illustrates expander hub EH positioned within head portion H offixation apparatus FA. As shown, expander hub EH is in what is referredto herein as an unlocked position, wherein the lowest surface ofexpander hub EH is at least substantially flat against upper surface 240of head portion H. In this position, there is little or no pressureexerted by outer wall 320 of expander hub EH against inside 260 of headportion H. As shown, uppermost surface 310 of expander hub EH is atleast substantially at the level of top end 250 of head portion H offixation apparatus FA. FIG. 7A also illustrates expander hub EH in thisunlocked position providing a top, plan view of expander hub EH withinhead portion H of fixation apparatus FA. Although lobes 330 areconsidered optional and not necessary for locking of fixation apparatusFA, when present, lobes 330 of expander hub EH can be aligned with slots220 of head portion H in the unlocked position shown in FIG. 7A. FIG. 9Aillustrates fixation apparatus FA positioned through a hole 400 of aplate P with expander hub EH in this unlocked position.

From the position shown in FIGS. 6 and 7, expander hub EH can be lockedin position in head portion H by simply suitably rotating expander hubEH. FIG. 7B illustrates initiation of this locking process as expanderhub EH has been rotated in a clockwise direction within head portion H.Although optional, lobes 330 as shown when present in FIG. 7B move outof alignment with slots 220 and can begin to exert pressure against wallsections 210 of head portion H.

FIG. 7C illustrates expander hub EH locked in position within headportion H as expander hub EH has been rotated even further from itsposition shown in FIG. 7B wherein lobes 330 are further away from slots220 and press against wall sections 210 of head portion H. As shown withthe disclosed configuration, each one of wall sections 210 has one oflobes 330 exerting outward force against it. In this manner, wallsections 210 of head portion H can be forced to move outwardlysufficient to press wall sections against any structure receivingfixation apparatus FA, as further described hereinbelow.

FIG. 8 of the drawings also illustrates expander hub EH in the lockedposition shown in FIG. 7C, but from a cross-sectional viewpoint. Asshown, the rotation of expander hub EH to reach this locked position hasvertically raised expander hub EH within head portion H such thatuppermost surface 310 of expander hub EH is now higher than the level oftop end 250 of head portion H of fixation apparatus FA. This elevationof expander hub EH results due to the incline or taper of upper surface240 of head portion H and the incline of lowest surface 300 of expanderhub EH. Since these inclined surfaces at least substantially match toallow expander hub EH to rest or fit at least like a puzzle pieceagainst upper surface 240 of head portion H when in the unlockedposition, rotation of expander hub EH to the locked position asdescribed understandably raises expander hub EH as shown as the inclinedsurfaces of upper surface 240 and lowest surface 300 move away from thisfitted position.

The reverse taper of inside 260 of wall sections 210 of head portion Hfacilitates retaining expander hub EH within head portion H as expanderhub EH changes elevation relative to head portion H. The incline ortaper of outer wall 320 of expander hub EH is designed for cooperationwith this reverse taper feature to allow desirable movement of expanderhub EH. The vertical or rising movement of expander hub EH within headportion H caused by rotation of expander hub EH causes outer wall 320 ofexpander hub EH, by its greater lower diameter and gradually decreasingupper diameter, to exert force on inside 260 of wall sections 210 ofhead portion H to force wall sections 210 outwardly, especially wheninside 260 of wall sections 210 has a gradual incline or taper oppositefrom outer wall 320 of expander hub EH.

FIGS. 9A and 9B of the drawings show a close-up view of fixationapparatus FA positioned through hole 400 of plate P. Expander hub EH isin an unlocked position in FIG. 9A where little or no pressure isexerted by wall sections 210 of head portion H against the inner wall ofhole 400 of plate P to hold or maintain fixation apparatus FA in anyspecific position or alignment. Expander hub EH is in its lockedposition in FIG. 9B where wall sections 210 of head portion H are forcedoutwardly by expander hub EH to exert sufficient pressure against theinner wall of hole 400 to maintain and lock fixation apparatus FA in adesired position and alignment it extends through hole 400 of plate P.Sufficient pressure can exist plate P to lock fixation apparatus FA inposition where the angle at which fixation apparatus FA is positionedthrough and within hole 400 of plate P can also be fixed and locked.

FIG. 10 illustrates, for exemplary purposes and without limitation, twoidentical fixation apparatuses FA extending through holes H of plate Pand partially into bone B. Plate P extends across a bone fracture lineFL and is held in position there to fixate fracture line FL. As can beappreciated by those of skill in the art, any suitable number offixation apparatuses could be used with any suitable configuration ofholes and plates as may be desired depending upon the situation. It isenvisioned of course that one or more plates such as plate P can beutilized with one or more fixation apparatuses FA, and that fixationapparatuses FA can be locked into any suitable position or alignment tofixating a fracture. For example, fixation apparatuses FA may extendthrough material other than bone immediately under a hole 400, such asthrough soft tissue or other non-bone material. As shown in FIG. 10,groove G of each fixation apparatus FA has allowed each head portion Hto self-counterbore into bone B so as to be below the upper surface ofbone B.

While any suitable drivers could be used in association with the subjectmatter described herein, FIGS. 11A, 11B, 11C, 12A, 12B, and 12C, 13 and14 illustrate, without limitation, exemplary embodiments of drivers thatcan be used. Placement driver PD is shown generally designated in FIGS.11A, 12A, 13 and 14 and can be used to drive fixation apparatus FA intosuitable material such as bone. Placement driver PD can be elongated andinclude a shaft portion 500 terminating in an end 502 configured to matewith recess 230 (FIGS. 3 and 4) within head portion H. As shown, end 502comprises a hexagonal shape to at least substantially matingly engagerecess 230. In this manner, rotation of placement driver PD forceslikewise rotation of fixation apparatus FA. Any suitable material ofconstruction can be used for placement driver PD, such as, for example,titanium.

Locking driver LD is shown generally designated in FIGS. 11B, 12B, 13and 14 and can be used to lock expander hub EH. Locking driver LD can beelongated and cannulated to fit over at least a portion of placementdriver PD as further described hereinbelow. Locking driver LD preferablyincludes a shaft 550 and terminates in one end 552 which is configuredto be inserted into the middle of expander hub EH to matingly engageinner wall 360. In this manner, rotation of locking driver LD forceslikewise rotation of expander hub EH. Any suitable material ofconstruction can be used for locking driver LD, such as, for example,titanium.

When shank portion SP is connected to head portion H, rescue driver RDis shown generally designated in FIGS. 11C, 12C, 13 and 14 and can beused to stop rotation of head portion H. This function of rescue driverRD is not necessary when shank portion SP is part of or connected withhead portion H. Rescue driver RD can be elongated and cannulated to fitover at least a portion of locking driver LD as further describedhereinbelow. Rescue driver RD preferably includes a shaft 600terminating in an end which can include tabs 602. Rescue driver RD canbe configured to be inserted into slots 200 of head portion H. In thismanner, rotation of rescue driver RD limits rotation of head portion Hduring locking. A handle 604 can be attached to the end of rescue driverRD opposite end 602 and used for gripping to apply rotational force torescue driver RD. Any suitable material of construction can be used forrescue driver RD, such as, for example, titanium.

FIG. 13 illustrates a nested and concentric configuration for thedrivers shown in FIGS. 11A-12C, and FIG. 14 illustrates the nestedconfiguration of drivers in contact with fixation apparatus FA whichextends through hole 400 of plate P. Placement driver PD is shown at thecenter, with locking driver LD positioned over or around placementdriver PD, but with end 500 of placement driver PD extending fartherthat end 550 of locking driver LD. Rescue driver RD is positioned overor around locking driver LD as shown. From this configuration, and ascan be readily appreciated by those of skill in the art, the drivers canbe used in cooperation with one another without having to remove eachbefore using another.

Exemplary Method of Use

It is envisioned that a fixation apparatus FA with the expander hub asdisclosed herein could be used in any manner known to those of skill inthe art based upon the present disclosure. When utilized for fixating abone fracture, as a non-limiting example, a surgeon can be presentedwith any suitable plate, such as plate P (such as shown in FIGS. 9A, 9B,10 and 14) for affixing across a bone fracture and a screw. Plate P canbe provided with any suitable configuration of holes definedtherethrough, such as hole 400 for receiving fixation apparatus FA. Theshape and size of hole 400 can be of any suitable shape and size, suchas spherical, as can be appreciated by those of skill in the art.Expander hub EH can be positioned (without being locked) in head portionH of fixation apparatus FA prior to packaging.

Plate P can be placed over an appropriate bone site, such as aboveand/or across a fracture line FL, as shown for example in FIG. 10, usingany suitable driver, such as placement driver PD shown in FIGS. 11A,12A, 13 and 14. By applying rotational pressure to placement driver PD,fixation apparatus FA can be driven into bone. As head portion H offixation apparatus FA passes through the entrance to hole 400 in plateP, the smaller outer diameter of expander hub EH, and, when present,lobes 330 resting within slots 200 of fixation apparatus FA, allow slots200 to narrow, and the outer diameter of fixation apparatus FA tocompress and slide through the opening of hole 400. Fixation apparatusFA can continue to be driven by placement driver PD until sufficient“lag” compression is obtained between plate P and head portion H offixation apparatus FA. At this point, fixation apparatus FA can rotaterelative to plate P about the center of hole 400.

Once fixation apparatus FA is positioned and suitably driven into bone Bthrough hole 400 by placement driver PD, locking driver LD can be used,without removing placement driver PD so as to hold fixation apparatus FAstationary, to rotate expander hub EH within head portion H of fixationapparatus FA to lock expander hub EH and thereby lock in place fixationapparatus FA. For this “locking” to occur, first lobes 330, whenpresent, of head portion H engage, with interference, inside 260 of wallsections 210 of head portion H. The rotation also causes the inclinationof upper surface 240 within head portion H and that of lowest surface300 of expander hub EH to force expander hub EH to elevationally andaxially move upward within head portion H of fixation apparatus FA. Thismovement engages the tapered surface of outer wall 320 of expander hubEH and that of inside 260 of wall sections 210 of head portion H furthercreating a radial, outward pressure on inside 260 of wall sections 210of head portion H. The outer diameter of fixation apparatus FA isthereby expanded, interfering with the inner diameter of the hole, suchas hole 400, of plate P, and creating friction, which locks the angleand alignment of fixation apparatus FA in place through hole 400.Fixation apparatus FA can advantageously be used with P plate wherebyfixation apparatus FA and plate P can compress bone separately fromlocking the fixation apparatus in a desired position. Also, the angle,alignment or position of fixation apparatus FA can be changed if desiredeven after locking of fixation apparatus FA.

It can therefore be seen that the angle and alignment of the fixationapparatus can be adjusted after placement of fixation apparatus FA, butprior to locking. This advantageously allows the position of fixationapparatus FA to be aligned using the angle of fixation apparatus FA, andadvantageously allows fixation apparatus FA to be held in place with thelocking aspect as described. Locking of fixation apparatus FA isoptional and is not a necessary step for fixating a bone fracture. Bynature of the design, expander hub EH cannot come free from the headportion of fixation apparatus FA, thus avoiding the potentialintroduction of a free foreign body under the skin. Even if expander hubEH were to become unlocked or disengaged after locking, the system asdisclosed herein would continue to function as well as conventional bonefixation systems. With fixation apparatus FA locked in place asdescribed herein, three potential undesirable failures of conventionalfixation apparatus systems that are avoided include torsional back-out,change of the angle of the fixation apparatus, and pull-out of thefixation apparatus.

Referring now to FIGS. 15 and 16, another embodiment of the presentsubject matter is shown. As known to those of skill in the art, bonefracture plates commonly used in orthopedics can comprise fixed-anglescrew orientations or variable-angle screw orientations. Plates withfixed-angle screw orientations can provide maximum stability in boneconditions of poor quality and facilitate screw placement by havingcommon screw orientations permanently fixed into the plate. However,disadvantages of these fixed-angle systems are known, such as theinability to allow for significant lagging or rotation of the screwafter contact with the plate to compress the bone and plate together.Plates with variable-angle screw orientations are also used, which allowa surgeon a choice of screw placement to most optimally treat apatient's individual condition. However, disadvantages of thesevariable-angle systems are also known, such as the possibility oflateral movement of the plate and screw after implantation is complete.

While both types of prior art systems can be made with locking featuresto provide additional bending resistance at the interface of the plateand screw, or to prevent screw loosening or back-out, it is desirous toprovide a system with the ability to lag plus the ability to restrictlateral toggling. As such, the fixation system of the present subjectmatter incorporates the advantages of fixation apparatus FA describedabove in a plate system allowing both fixed-angle (laterally-fixed) andvariable-angle (laterally-variable) bone fastener orientation. Moreparticularly with reference to FIG. 15, fixation system FS can include adevice which can be a planar device, such as plate P described above,having one or more holes such as holes 400 and a planar surface 412(which abuts a bone surface when installed). It is envisioned that plateP can be in any shape (round washer, etc.) and can be constructed of anybiocompatible material such as titanium, titanium alloy, stainlesssteel, cobalt chromium, or any absorbable material such as PLLA orpolycarbonate. Holes 400 can be generally spherical, conical, or roundedat base portion 406 closest to the bone surface and preferably has wallsof a cylindrical shape (or other constant geometric shape).

Fixation system FS further can include at least one laterally-variablefixation apparatus FA, as described above with reference to FIGS. 1 and2. Variable fixation apparatus FA can have a generally spherical,conical, or rounded shaped head portion H wherein variable fixationapparatus FA can rotate about a longitudinal axis as shown by arrow A3and is also capable of toggling laterally relative to planar surface 412of plate P, as shown by arrow A4. With reference to FIG. 16, fixationsystem FS further can include at least one laterally-fixed fixationapparatus FA′. Fixed fixation apparatus FA′ can be generally comparableto variable fixation apparatus FA as described above, but can comprisewall sections 210′ designed to provide a generally cylindrical shaped(or other constant geometric shape) head portion H′. Cylindrical shapedhead portion H′ of fixed fixation apparatus FA′ can engage thecylindrical walls of hole 400 as shown in FIG. 15 so as to preventangulation of fixed fixation apparatus FA′ by engaging more contactsurface of hole 400 in plate P. This design allows for rotation of fixedfixation apparatus FA′ about a longitudinal axis as shown by arrow A3′,but can restrict lateral toggle movement relative to planar surface 412of plate P. Both variable fixation apparatus FA and fixed fixationapparatus FA′ can include expander hub EH, EH′ for locking of fixationapparatus FA, FA′ to plate P, the operation of which is described inmore detail above. More particularly, expander hub EH, EH′ can berotated using any suitable driver to force at least one or more of headwall sections 210, 210′ outwardly against the walls of hole 400 untilsufficient pressure is exerted by wall sections 210, 210′ against thewalls of hole 400 to maintain and lock fixation apparatus FA, FA′ toplate P.

Either variable fixation apparatus FA or fixed fixation apparatus FA′can have additional locking features for locking of fixation apparatusFA, FA′ to plate P. Such locking features can include a tab, ring, orprotrusion formed on fixation apparatus FA, FA′ that interlocks with areceiving section formed in hole 400 of plate P. Alternatively, fixationapparatus FA, FA′ can have a receiving section that interlocks with aprotruding section formed on plate P. As described above, since theheads of fixation apparatus FA, FA′ may be thicker than desired(especially if additional features, such as locking, are included), itmay be necessary to countersink into the bone to allow the fixationapparatus to sit in a thinner plate. As such, fixation apparatus FA, FA′may be self-counterboring such as though the addition of groove G (seeFIGS. 2 and 16) that can be defined in the lower portion of head portionH, H′. Finally, holes 400 formed in plate P can be designed to alloweither of variable fixation apparatus FA or fixed fixation apparatus FA′to be used therein. Alternatively, plate P can combine different typesof holes 400 to make some specifically adaptable to receive variablefixation apparatuses FA and others specifically adaptable to receivefixed fixation apparatuses FA′.

Referring now to FIGS. 17A, 17B and 18, a further embodiment of thepresent subject matter is shown. It is known in the art that sometimesbone fasteners, such as screws, may be too large or otherwiseundesirable for fixating small fragments of bone. In these situations,surgeons may use a guide (threaded or non-threaded), such as a rod or aK wire, to stabilize the bone fragments. When such guides are used forsuch stabilization, it is known that the guides can sometimes migratelongitudinally which can result in protrusion of the guide intosensitive tissues or possibly destabilization of the bone fragments thatare being held together. As such, it is desirable to have a system thatcan constrain orthopedic guides to a plate for fixating of bonefragments without the aforementioned undesirable effects of guidemigration.

As illustrated in FIGS. 17A, 17B and 18, a guide fixation apparatusgenerally designated GFA is provided to fixate an orthopedic guide OG toa plate P. All components of guide fixation apparatus GFA can beseparate and independent of one another. As shown, guide fixationapparatus GFA can include a head portion H and expander hub EH, both ofwhich are substantially similar in design concept to those described inmore detail above with reference to fixation apparatus FA (separate andindependent from shank portion SP). More particularly, head portion Hcan have one or more slots, such as slots 200, defined through portionsof the wall of head portion H to create wall sections 210. Additionally,expander hub EH can have slots or slits (not shown), or be made of amalleable material, such that wall sections 360 are moveable inwardly oroutwardly when under pressure. Expander hub EH can be positioned withinhead portion H in a disengaged or unlocked position wherein wallsections 210 of head portion H are not forced outwardly, and an engagedor locked position wherein wall sections 210 of head portion H areforced outwardly sufficient to lock guide fixation apparatus GFA in apredetermined position within plate P. It is additionally envisionedthat when expander hub EH is in the engaged or locked position,orthopedic guide OG can also be locked, such as by forcing inner wallsections 360 of expander hub EH inwardly, so as to prevent anylongitudinal migration of guide OG within plate P. It is additionallyunderstood that once guide fixation apparatus GFA has been engaged orlocked such that guide OG is fixed laterally and longitudinally withinplate P, the length of guide OG may be adjusted through the use ofpre-stressed or pre-fatigued regions or notches (not shown) formed inguide OG wherein portions of guide OG can be broken off at certainlengths, such as for example a length generally flush with uppermostsurface 310 of expansion hub EH.

Referring now to FIG. 19, systems and methods are provided forcompressing two bone portions B, B′, which are separated by a break orfracture line FL. The system can include an orthopedic guide OG andfirst and second compression fixation systems CS, CS′. Each compressionsystem CS, CS′ includes a plate P and a guide fixation apparatus GFA,the structure and function of which is described above. In operation, asurgeon can drive an orthopedic guide OG across first and second boneportions B, B′ and fracture line FL. Plates P and guide fixationapparatuses GFA of first and second compression systems CS, CS′ can bepositioned against first and section bone portions B, B′, respectively,and guide OG can be positioned within holes 400 of plates P and throughopenings defined within guide fixation apparatuses GFA of first andsecond compression systems CS, CS′. First and second compression systemsCS, CS′ and respective first and second bone portions B, B′ can then becompressed together to form a unitary structure. After compression offirst and second bone portions B, B′ is complete, each guide fixationapparatus GFA can be rotated using a suitable driver into an engaged orlocked position as described above wherein guide OG is locked laterallyand longitudinally with respect to each plate P of first and secondcompression systems CS, CS′, thereby holding first and second boneportions B, B′ in compression. Once locking is complete, portions ofguide OG can be removed, for example at predetermined notch points asdescribed above.

It will be understood that various details of the subject matterdisclosed herein may be changed without departing from the scope of thesubject matter. Furthermore, the foregoing description is for thepurpose of illustration only, and not for the purpose of limitation.

1. A fixation system for fixating bone, the fixation system comprising:(a) a planar fixation device having a planar surface and defining atleast one opening therethrough, the opening having side walls definingan at least generally cylindrical shape; and (b) a laterally-fixedfixation apparatus comprising: (i) an at least generally cylindricalshaped head portion comprising a plurality of outer wall sections atleast partially surrounding a central hollow area, the head portionhaving an inner bottom surface below the central hollow area; (ii) anexpander hub adapted for positioning at least partially within thecentral hollow area and seated at least partially on the inner bottomsurface of the cylindrical head portion, the expander hub beingrotatable to force at least one or more of the outer wall sections ofthe head portion outwardly; and (iii) wherein the fixation apparatus isadapted to be positioned at least partially in the opening of the planarfixation device where the expander hub of the fixation apparatus can berotated to force at least one or more of the outer wall sections of thehead portion outwardly against a portion of the side walls of theopening to lock the fixation apparatus in a desired position in theopening and further wherein the fixation apparatus is adapted forrotation about a longitudinal axis of the fixation apparatus withoutlateral toggle movement relative to the planar surface of the planarfixation device while the fixation apparatus is positioned at leastpartially in the opening.
 2. The fixation system according to claim 1wherein the planar fixation device is a plate.
 3. The fixation systemaccording to claim 1 wherein the planar fixation device is a washer. 4.The fixation system according to claim 1 wherein the laterally-fixedfixation apparatus comprises a shank portion extending from the headportion.
 5. The fixation system according to claim 4 wherein the shankportion is integral and formed as an extension of the head portion. 6.The fixation system according to claim 4 wherein the shank portion isseparate from and extends from the head portion.
 7. The fixation systemaccording to claim 4 wherein the shank portion is threaded.
 8. Thefixation system according to claim 4 wherein the shank portion isnon-threaded.
 9. The fixation system according to claim 1 wherein thehead portion of the laterally-fixed fixation apparatus isself-counterboring.
 10. The fixation system according to claim 1 whereinthe wall sections of the head portion of the fixation apparatus comprisea plurality of wall sections extending from a portion of the fixationapparatus, the wall sections defining slots between each wall sectionwhich provide a space between adjacent wall sections.
 11. The fixationsystem according to claim 10 wherein the slots are at leastsubstantially parallel to one another.
 12. The fixation system accordingto claim 11 comprising a shank portion extending from the head portionand wherein the slots of the head portion extend in a direction at leastsubstantially parallel to an axis along which the shank portion extends.13. The fixation system according to claim 1 wherein the inner bottomsurface of the head portion of the fixation apparatus defines a recessedopening.
 14. The fixation system according to claim 1 wherein the innerbottom surface of the head portion of the fixation apparatus furthercomprises an at least partially inclined bottom surface.
 15. Thefixation system according to claim 14 wherein the expander hub has abottom surface that is at least partially inclined.
 16. The fixationsystem according to claim 1 wherein the expander hub of the fixationapparatus is at least generally cylindrical.
 17. The fixation systemaccording to claim 16 wherein the expander hub comprises an inclinedbottom surface.
 18. The fixation system according to claim 1 wherein theexpander hub of the fixation apparatus comprises a plurality of lobes onan outer surface of the expander hub.
 19. The fixation system accordingto claim 18 wherein the lobes on the expander hub extend outwardly. 20.The fixation system according to claim 1 wherein the expander hub of thefixation apparatus comprises a plurality of annular recesses forreceiving a driver for rotating the expander hub.
 21. A fixation systemfor fixating bone, the fixation system comprising: (a) a planar fixationdevice having a planar surface and defining a plurality of openingstherethrough, the openings having side walls defining an at leastgenerally cylindrical shape; (b) at least one laterally-variablefixation apparatus comprising: (i) an at least generally sphericalshaped head portion comprising a plurality of outer wall sections atleast partially surrounding a central hollow area, the head portionhaving an inner bottom surface below the central hollow area; (ii) anexpander hub adapted for positioning at least partially within thecentral hollow area and seated at least partially on the inner bottomsurface of the spherical head portion, the expander hub being rotatableto force at least one or more of the outer wall sections of the headportion outwardly; and (iii) wherein the laterally-variable fixationapparatus is adapted to be positioned at least partially in an openingof the planar fixation device where the expander hub of thelaterally-variable fixation apparatus can be rotated to force at leastone or more of the outer wall sections of the head portion outwardlyagainst a portion of the side walls of the opening to lock thelaterally-variable fixation apparatus in a desired position in theopening and further wherein the laterally-variable fixation apparatus isadapted for rotation about a longitudinal axis of the laterally-variablefixation apparatus and is adapted for lateral toggle movement relativeto the planar surface of the planar fixation device while thelaterally-variable fixation apparatus is positioned at least partiallyin the opening; and (c) at least one laterally-fixed fixation apparatuscomprising: (i) an at least generally cylindrical shaped head portioncomprising a plurality of outer wall sections at least partiallysurrounding a central hollow area, the head portion having an innerbottom surface below the central hollow area; (ii) an expander hubadapted for positioning at least partially within the central hollowarea and seated at least partially on the inner bottom surface of thecylindrical head portion, the expander hub being rotatable to force atleast one or more of the outer wall sections of the head portionoutwardly; and (iii) wherein the laterally-fixed fixation apparatus isadapted to be positioned at least partially in an opening of the planarfixation device where the expander hub of the laterally-fixed fixationapparatus can be rotated to force at least one or more of the outer wallsections of the head portion outwardly against a portion of the sidewalls of the opening to lock the laterally-fixed fixation apparatus in adesired position in the opening and further wherein the laterally-fixedfixation apparatus is adapted for rotation about a longitudinal axis ofthe laterally-fixed fixation apparatus without lateral toggle movementrelative to the planar surface of the planar fixation device while thelaterally-fixed fixation apparatus is positioned at least partially inthe opening.
 22. A fixation system for fixating an orthopedic guide, thefixation system comprising: (a) a planar fixation device having a planarsurface and defining at least one opening therethrough; and (b) a guidefixation apparatus adapted for receiving an orthopedic guide, thefixation apparatus comprising: (i) a head portion comprising a pluralityof outer wall sections at least partially surrounding a central hollowarea, the head portion having an inner bottom surface below the centralhollow area, the inner bottom having an opening defined therein forreceiving the orthopedic guide; (ii) an expander hub adapted forpositioning at least partially within the central hollow area and seatedat least partially on the inner bottom surface of the head portion, theexpander hub having side walls and a bottom surface having an openingdefined therein adapted for receiving the orthopedic guide, and theexpander hub being rotatable to force at least one or more of the outerwall sections of the head portion outwardly; and (iii) wherein the guidefixation apparatus is adapted to be positioned at least partially in theopening of the planar fixation device where the expander hub of thefixation apparatus can be rotated to force at least one or more of theouter wall sections of the head portion outwardly against a portion ofthe side walls of the opening to lock the fixation apparatus in adesired position in the opening.
 23. The fixation system according toclaim 22 wherein the planar fixation device is a plate.
 24. The fixationsystem according to claim 22 wherein the planar fixation device is awasher.
 25. The fixation system according to claim 22 wherein the wallsections of the head portion of the guide fixation apparatus comprise aplurality of wall sections extending from a portion of the guidefixation apparatus, the wall sections defining slots between each wallsection which provide a space between adjacent wall sections.
 26. Thefixation system according to claim 25 wherein the slots are at leastsubstantially parallel to one another.
 27. The fixation system accordingto claim 22 wherein the inner bottom surface of the head portion of theguide fixation apparatus further comprises an at least partiallyinclined bottom surface.
 28. The fixation system according to claim 27wherein the expander hub bottom surface is at least partially inclined.29. The fixation system according to claim 22 wherein the expander hubof the guide fixation apparatus is at least generally cylindrical. 30.The fixation system according to claim 29 wherein the expander hubcomprises an inclined bottom surface.
 31. The fixation system accordingto claim 22 wherein the expander hub of the guide fixation apparatuscomprises a plurality of lobes on an outer surface of the expander hub.32. The fixation system according to claim 31 wherein the lobes on theexpander hub extend outwardly.
 33. The fixation system according toclaim 22 wherein the expander hub of the guide fixation apparatuscomprises a plurality of annular recesses for receiving a driver forrotating the expander hub.
 34. The fixation system according to claim 22wherein the side walls of the expander hub are moveable inwardly to lockan orthopedic guide in a desired position within the expander hubopening.
 35. A system for compressing bone portions, the systemcomprising: (a) an elongated orthopedic guide having first and secondends; (b) first and second compression fixation systems, each fixationsystem comprising: (i) a planar fixation device having a planar surfaceand defining at least one opening therethrough, the planar fixationdevice adapted to be positioned against a bone portion; and (ii) a guidefixation apparatus adapted for receiving an orthopedic guide, thefixation apparatus comprising: 1) a head portion comprising a pluralityof outer wall sections at least partially surrounding a central hollowarea, the head portion having an inner bottom surface below the centralhollow area, the inner bottom having an opening defined therein forreceiving the orthopedic guide; 2) an expander hub adapted forpositioning at least partially within the central hollow area and seatedat least partially on the inner bottom surface of the head portion, theexpander hub having side walls and a bottom surface having an openingdefined therein adapted for receiving the orthopedic guide, and theexpander hub being rotatable to force at least one or more of the outerwall sections of the head portion outwardly; and 3) wherein the guidefixation apparatus is adapted to be positioned at least partially in theopening of the planar fixation device where the expander hub of thefixation apparatus can be rotated to force at least one or more of theouter wall sections of the head portion outwardly against a portion ofthe side walls of the opening to lock the fixation apparatus in adesired position in the opening; and (c) wherein the planar fixationdevice and guide fixation apparatus of the first fixation system areadapted to receive the first end of the orthopedic guide and the planarfixation device and guide fixation apparatus of the second fixationsystem are adapted to receive the second end of the orthopedic guide.36. The system according to claim 35 wherein the planar fixation deviceof each of the first and second fixation systems is a plate.
 37. Thesystem according to claim 35 wherein the planar fixation device of eachof the first and second fixation systems is a washer.
 38. The systemaccording to claim 35 wherein the side walls of the expander hub of eachof the first and second fixation systems are moveable inwardly to lockthe orthopedic guide in a desired position within the expander hubopening of each respective fixation system.
 39. A method of compressingbone portions, the method comprising: (a) providing first and secondcompression fixation systems, each fixation system comprising: (i) aplanar fixation device having a planar surface and defining at least oneopening therethrough; and (ii) a guide fixation apparatus for receivingan orthopedic guide, the fixation apparatus comprising: 1) a headportion comprising a plurality of outer wall sections at least partiallysurrounding a central hollow area, the head portion having an innerbottom surface below the central hollow area, the inner bottom having anopening defined therein for receiving the orthopedic guide; 2) anexpander hub adapted for positioning at least partially within thecentral hollow area and seated at least partially on the inner bottomsurface of the head portion, the expander hub having a bottom surfacehaving an opening defined therein for receiving the orthopedic guide,and the expander hub being rotatable to force at least one or more ofthe outer wall sections of the head portion outwardly; and 3) whereinthe guide fixation apparatus is adapted to be positioned at leastpartially in the opening of the planar fixation device where theexpander hub of the fixation apparatus can be rotated to force at leastone or more of the outer wall sections of the head portion outwardlyagainst a portion of the side walls of the opening to lock the fixationapparatus in a desired position in the opening; (b) driving anorthopedic guide into first and second bone portions; (c) positioningthe planar fixation device and guide fixation apparatus of the firstfixation system against the first bone portion and positioning theplanar fixation device and guide fixation apparatus of the secondfixation system against the second bone portion; (d) positioning theorthopedic guide in a desired alignment with respect to the planarfixation devices of the first and second fixation systems; (e)compressing the first and second fixation systems wherein theirrespective first and second bone portions are compressed together; and(f) after compressing the bone, locking the guide fixation apparatus inposition relative to the planar fixation device for each of the firstand second fixation systems.
 40. The method of claim 39 wherein the stepof locking the guide fixation apparatus in position relative to theplanar fixation device for each of the first and second fixation systemscomprises rotating each respective expander hub to force at least onewall section of each respective head portion of each respective fixationapparatus outwardly.